During a recent discussion with healthcare professionals (HCPs) and patient representatives, a blind poll revealed that every attendee believed that the ‘public is not sufficiently informed on clinical trials’. In addition to this, in 2009, Bower et al reported that in a study of 114 UK trials, only 31% managed to recruit ≥ 100% of the target number of patients. Furthermore, it found that 45% of these trials did not manage to recruit even 80% of the target number.

A significant barrier preventing recruitment into trials is the lack of clear understanding and a general fear of the risks involved in participating. By listening to the patient voice, there is a chance to increase engagement and involvement within the general public.

Patients can sometimes see themselves as ‘guinea pigs’ in the drug development process. They often do not have a clear knowledge or understanding of the risks involved in participating in a trial. To alleviate some of this concern, some pharmaceutical companies are working with trial centres and patient representatives to find ways to disseminate this information in an accessible and understandable way to patient populations.

A good example of this is revisiting the way we acquire informed consent from patients for a clinical trial. Informed consent forms are often very long and complex documents, written in language that is not easily comprehensible by the main audience that needs to understand it – the patients. By supplementing these forms with more digestible content, such as animated video summaries or infographic representations of the information, patients can better understand the terms that they are consenting to. Additionally, providing platforms for patients and representatives to provide feedback on the best way to present the information, and the content itself, can be very valuable in generating materials that ensure maximum usability.

Another barrier that is present in the community is the accessibility of content in languages other than English. For trials that take place in multiregional settings, it is important to consider all the individuals that may be involved and allow enough time to adapt materials to local languages, thereby maximising recruitment potential.

It is important to remember that clinical trials cannot ever be a ‘one-size-fits-all’ situation, so adapting to localities not only increases the potential to involve more patients but also empowers them to undertake their own learning to increase their knowledge of the trial and potential treatment.

Additionally, it is crucial to consider where this information may be best distributed. Although clinical trial information is readily available on ClinicalTrials.gov, it is not suitable for a patient population. Patients have stated in the past that they are concerned about the information they read on the site due to lack of understanding of the content. By involving patient organisations and advocacy groups in recruitment and engagement, you can reduce patient concern by providing them with expert representatives that understand the therapy area and how to discuss it in an accessible way.

There are many reasons why a patient may not participate in a trial, or may drop out. A large factor affecting this is the commitment the patient must make to take part. Whether it’s due to time, finances or travel, there are many sacrifices a patient must make to be involved. To minimise the amount of resistance from participants, it is a good idea to involve patient representatives in the development of the clinical trial to highlight areas of concern.We are seeing positive steps towards improving patient-centric trial design within the pharmaceutical industry, with the advent of mock clinical trials. In this set-up, patient and HCP representatives feed into potential trial set-ups and procedures to identify which sections may need to change to better recruit, engage and provide a positive experience for patients.

When conducting a recent mock trial simulation, we saw HCPs and patients role-play, in a virtual setting, the initial screening visit that would take place early in the trial. Using a pre-read document and visuals that we developed in collaboration with the pharmaceutical company, they discussed all elements of being involved in such a trial. The meeting and visuals were translated and presented to patients in their preferred language. Following this interaction, each patient and HCP was debriefed individually to provide insights on which aspects of the trial would or would not work in the real world, as well as providing feedback on the materials used and how they could be adapted for future use.

The feedback gathered from these interactions is extremely valuable and unlike any feedback gathered through other methods. By utilising innovative concepts to gather and implement thoughts from real-life trial participants, we can update trial designs before they take place. A trial that better suits all individuals involved could likely lead to better enrolment and retention, and provide patients with a more comfortable experience when taking part. Of course, not all elements of a trial can be adapted to patient needs, but knowing that you have done as much as possible to benefit the patient is advantageous to you, the trial staff and the patients.

Furthermore, with the advances in virtual healthcare and telemedicine, concepts like this are much more accessible and cost-effective than ever before. We now live in a world where individuals are less afraid of being actively involved in online consultations and appointments. Some still have reservations, and there is still progress to be made outside the clinical trial remit to engage and support those patients. However, utilising these methods allows for more people to become involved in the clinical trial process. It allows for more representation from various regions to ensure their voices are heard as an important part of the development process.

The importance of telemedicine has been seen in clinical trials previously. However, most trials still require some level of face-to-face interaction. For patients who live in more remote areas or have decreased mobility, decentralised clinical trials could be a viable solution.

Utilising a hub-and-spoke model, we can look at using a central hospital ‘hub’ to run and manage the trials while having regional ‘spoke’ sites where screening, procedures and administration of medicine are completed. This approach could further ensure long-term involvement in trials for patients by reducing the time and cost burdens associated with travelling. Moreover, it may be appropriate to run more hybrid trials in the future, with appointments available at different sites or even consultations within the home. As all patients are not homogenous, our approach to undertaking clinical trials must be flexible and adapt to the needs of the patient. In any case, a clear line of support is needed throughout, with an open environment for patients to access clear information and support as required.

Throughout the clinical trial development process, there are multiple opportunities for organisers to gather and consider patient insights. Each time patients are asked for their input into the process, it can lead to important changes to the trial design that may increase the likelihood of improved recruitment and retention.

For patients to become engaged in a trial, they need to understand what they are signing up to and what inclusion could mean to them. There is a responsibility for those organising and planning trials to provide these materials in the most appropriate format and languages. The aim of a clinical trial is often to develop a new, more effective treatment but there is also the goal of empowering patients to make informed decisions about their healthcare management to enact meaningful change for themselves and others in similar positions.

James Falcous is an Account Manager (Patient Engagement) at Nucleus Global